Senior Quality Assurance EngineerAutonomous Medical Devices Incorporated • United States
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Senior Quality Assurance Engineer
Autonomous Medical Devices Incorporated
- United States
- United States
À propos
is a California-based company tenaciously focused on developing and manufacturing innovative diagnostic devices. Headquartered in Santa Ana, CA, AMDIs ISO:13485 / MDSAP?certified 110,000 sq ft facility produces the Fast PCR Mini Respiratory Panel. Summary of Position
Are you a detail?driven professional with a passion for quality and innovation in medical devices? We are seeking a
Senior Quality Assurance (QA) Engineer
to help ensure that our products meet the highest standards of safety, effectiveness, and compliance. The Senior QA Engineer will guide design control and product realization across R&D, Engineering, and Operations, shaping product development, improving design processes, and maintaining robust documentation. Location
On?site in Santa Ana, CA. Candidates living within a 25?mile range are preferred. Essential Duties and Responsibilities Provide QA guidance throughout design control and product realization to meet applicable regulations and standards (ISO 13485, 21 CFR Part 820, FDA guidance, ISO/IEC standards). Collaborate with R&D, Engineering, and Operations to support new product development and improve design. Lead risk management activities by creating, reviewing, and reporting on risk management plans and documents. Write or review validation protocols and reports. Partner with supplier quality and supply chain groups to ensure effective development of product suppliers. Verify configuration management and risk analysis records for accuracy and maintenance. Support software development activities to ensure regulatory compliance. Lead design transfer activities related to product quality and regulatory compliance. Ensure design changes follow current change control requirements. Participate in QMS processes, including NCR investigations, CAPA, internal audits, and process validations. Complete assigned tasks on schedule and propose resolutions for issues affecting development timelines. Coordinate resolution of potential quality assurance deficiencies during product realization. Engage in additional projects and duties as assigned.
Qualifications Required for Position
Bachelors degree in engineering, science or related field (Advanced degree preferred). Minimum of 7 years of quality engineering experience in the medical device industry; at least 2 years in new product design and development. Hands?on experience with design control processes and mastery of ISO 13485:2016 and 21 CFR Part 820. Hands?on experience with risk management and mastery of ISO 14971. Well organized and detail?oriented. Strong documentation skills, including clear, concise verification/validation/qualification protocols and reports. Strong interpersonal skills and a team?player attitude, establishing professional partnerships with colleagues and suppliers. Ability to interpret trends and data, translating insights into actions and improvements. Strong verbal and written communication skills. Proficient with QMS software, tech?savvy and quick to learn new tools.
Desired Skills and Traits
Contributes to a collaborative and inclusive work environment. Results?orienteddrives progress and excellence. High standards, ownership, and investment in outcomes. Proactive helper, maintaining a positive attitude. Experience with software development and V&V; mastery of ISO, IEC, FDA requirements for software. IVD medical device experience. Quality engineering certification (ASQ CQE or CQA) desired.
Work Environment
In?person, requiring computer work for extended periods. Occasional work in production and laboratory environments.
Salary Range
The estimated base salary range is $100,000 $135,000 annually, adjusted based on qualifications and role level. Benefits
Company?provided lunch at on?site locations. 401(k) match. Health insurance (100% employer paid) including medical, dental, vision, and life insurance. Competitive vacation, sick days, and paid holidays. Tuition reimbursement. Casual dress code. Employee discounts on theme parks, movies, hotels, rental cars, etc. Monthly company?wide socials and activities.
Equal Opportunity Employer
We are an equal?opportunity employer and encourage people from all backgrounds to apply. All qualified applicants receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, veteran status, or any other protected characteristic under federal, state, or local law. Senior Level
Mid?Senior level
Employment Type
Full?time
Job Function
Information Technology Industries: Wireless Services, Telecommunications, and Communications Equipment Manufacturing
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Compétences linguistiques
- English
Avis aux utilisateurs
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